PICSCOUT

过去几年对于试验注册非常重要，因为它在研究中所扮演的作用得到了全球倡议和journal publication requirements。并有充分的理由；试验注册对于研究透明度至关重要，最小化偏见和selective reporting，除了公开展示目前正在进行的研究以在需要的情况下引导有价值的研究资金和努力，以避免重复。

在2008年，赫尔辛基的声明被修改为“Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject”。这是潜在的注册（而不是回顾性注册，这是在第一位参与者入学后的注册）；该政策是广为人知的，许多期刊都需要或鼓励它，但是我们是否在注册表层面看到了这一点？

十年的强制性审判注册 - 数据怎么说？

We looked at registry records in theISRCTN注册表*, which is curated and administered by BMC, to investigate trends.

尽管ISRCTN记录的绝对数量正在继续增长，但我们在预期注册时并没有看到相同的情况。有趣的是，尽管在2010年达到顶峰，但在过去的四年中，它保持相对稳定，在开始招募之前注册了不到三分之二的研究。

尽管潜在的注册仍然是最终目标，但实际上，当前信息总比没有好（关于编辑的回顾性注册困境的完整讨论是这里）。

竞选活动的势头异议和Restoring Invisible and Abandoned Trials(RIATs), which urge researchers to register and publish past and completed trials, continues to grow. Are we seeing this slight decrease in prospective registration as the backlog of old trials are being registered and published, or is something else at play? It’s also interesting to consider whether requiring prospective trial registration at the time of submitting to a journal is just too late in the process.

进化平台

这不仅仅是数字增长；随着提交的增加，ISRCTN提供了一个适应性的平台，该平台经常进行评估和更新，以跟上整个临床试验领域的准则和进展。

数字对象标识符（DOIS）有助于将所有结果出版物与试用记录联系起来，而与出版商无关，并增加了数字出版物的永久性。

Have you ever considered participating in a trial? Clinical research would not happen without patients and volunteers! In2011年，ISRCTNrecognized the importance of this, becoming the data source for the launch of英国临床试验门户, a Department of Health initiative to encourage trial participation. We added a plain English summary to each ISRCTN trial record, to make current research more accessible and understandable to those who play such a crucial part.

2012SAW数字对象标识符（DOIS）添加到所有记录中，有助于将所有结果出版物与试用记录联系起来，而不论发布者不管出版商，并增加了数字出版物的永久性。

ISRCTNunderwent its biggest revamp to date in2014, when the site re-launched. This improved usability and incorporated new fields, such asOrcID IDs (a unique identifier directly linking trials to researchers) and publication plans. A significant update introduced here was the retrospective/prospective flag system, automatically generated using compulsory recruitment start and end dates to clearly label a trial’s registration status, as this developed as an increasingly important factor for publication.

最近2017ISRCTN根据添加到WHO data set，鼓励试验者分享道德批准的细节，出版前的基本结果以及他们围绕数据共享的计划。

Collaboration is crucial

Clinical trial conduct is a vast, progressing field that would be almost impossible for ISRCTN to stay on top of alone!与外部合作伙伴，其他注册机构和全球倡议的关系提供注册开发方面的指导和支持。

与National Institute for Health Research(NIHR), a UK government body that coordinates and funds research for the National Health Service (NHS). As a significant funder of health and care research in the UK, the NIHR funds an increasing number of records published in ISRCTN. Matt Westmore, Operations Director at NIHR Evaluation, Trials and Studies Co-ordinating中心认识到“working in partnership is a much more powerful and efficient way of realising the value of registries.”

作为领导Adding Value in Researchinitiative, which won a2017Cochrane-REWARD prize for reducing waste in research，马特认为注册表的重要性是这样：

“当实际上重复同一试验时，缺乏注册是浪费的主要来源，因为结果尚不清楚，并且因为世界不知道它正在进行。Registration is important to prevent unintentional duplication and provide an audit point for later accountability. What’s particularly important is that registries are about on-going studies, because there’s almost nowhere else you can find out about that, but it’s also about what has happened, as so many trials go unpublished. Often the only place that there’ll be a record that a trial ever existed is within a clinical trial registry.

缺乏注册对科学不利，对患者有害。

这不仅适用于临床试验。将来，我们希望看到整个研究途径，不同研究方法和不同注册表之间的更大联系和互动 - 它需要成为更加协调和合并的观点。

最终，我们希望能够说全部studies are registered in an appropriate publicly accessible registry at study inception and easy to find through simple searches. It is not just NIHR that thinks that. An internationalforum of fundershas agreed this as an important guiding principle.”

那么，ISRCTN即将到来？

为了解决，新的ISRCTN数据库经理克莱尔·安妮（Claire Amyard）自今年3月加入团队以来就对ISRCTN进行了一些反思：

“令我震惊的是ISRCTN的是试验的多样性 - ISRCTN具有适应任何类型的干预，观察或试验设计的灵活性。我想提高ISRCTN的搜索和输出功能，以便研究人员更容易检查类似的试验和比较设计，并区分有和没有结果的试验。我们还计划开发更彻底的出版摘要。”

Enjoyed our post on trial registration? Explore some more hot topics that we have collated as part of Clinical Trials Day 2018这里!

想测试您的试用注册知识吗？带我们ISRCTNquiz。

*The ISRCTN RegistryISRCTN是一项开放访问，可自由访问和可搜索的临床试验注册表，对任何旨在评估健康干预措施在人口中的疗效的研究开放，ISRCTN可确保试验记录包含世界卫生组织（WHO）所需的基本信息。